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A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010) (reSURFACE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722331
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Results First Posted : June 13, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Tildrakizumab 200 mg
Drug: Tildrakizumab 100 mg
Drug: Matching Placebo
Enrollment 772
Recruitment Details The tables below present the Participant Flow for the Base Study only (Weeks 0 to 64: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 36 weeks).
Pre-assignment Details  
Arm/Group Title Tildrakizumab 200 mg (Parts 1, 2 & 3) Tildrakizumab 100 mg (Parts 1, 2 & 3) Tildrakizumab 100 mg (Parts 1 & 2) Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) Placebo (Part 1) Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Hide Arm/Group Description Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3). Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3). Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3). Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3). Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Period Title: Part 1
Started 308 249 41 19 9 72 74
Completed 298 249 32 19 0 72 74
Not Completed 10 0 9 0 9 0 0
Reason Not Completed
Adverse Event             5             0             0             0             0             0             0
Lack of Efficacy             0             0             1             0             2             0             0
Lost to Follow-up             1             0             2             0             1             0             0
Physician Decision             0             0             3             0             1             0             0
Pregnancy             1             0             0             0             0             0             0
Progressive Disease             0             0             0             0             1             0             0
Protocol Violation             1             0             0             0             1             0             0
Withdrawal by Subject             2             0             3             0             3             0             0
Period Title: Part 2
Started 298 249 31 [1] 19 0 72 74
Completed 279 249 0 19 0 62 67
Not Completed 19 0 31 0 0 10 7
Reason Not Completed
Adverse Event             3             0             0             0             0             1             0
Lack of Efficacy             3             0             11             0             0             3             3
Lost to Follow-up             0             0             3             0             0             1             1
Non-Compliance with Study Drug             1             0             1             0             0             0             0
Physician Decision             0             0             2             0             0             0             0
Pregnancy             0             0             0             0             0             1             0
Progressive Disease             0             0             1             0             0             0             0
Protocol Violation             1             0             0             0             0             0             0
Withdrawal by Subject             5             0             3             0             0             2             2
Other Protocol Specified Criteria             6             0             10             0             0             2             1
[1]
1 participant who completed Part 1 did not enter Part 2
Period Title: Part 3
Started 279 249 0 19 0 62 67
Completed 264 232 0 18 0 59 65
Not Completed 15 17 0 1 0 3 2
Reason Not Completed
Adverse Event             2             2             0             1             0             0             0
Death             1             0             0             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0             0
Lost to Follow-up             3             4             0             0             0             1             0
Non-Compliance with Study Drug             0             1             0             0             0             0             0
Physician Decision             1             1             0             0             0             0             1
Protocol Violation             2             1             0             0             0             0             0
Withdrawal by Subject             4             7             0             0             0             2             1
Other Protocol Specified Criteria             1             1             0             0             0             0             0
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Total
Hide Arm/Group Description Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks. Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks. Matching placebo administered SC once a week at Weeks 0 and 4. Total of all reporting groups
Overall Number of Baseline Participants 308 309 155 772
Hide Baseline Analysis Population Description
Overall Number of Baseline Participants includes randomized participants according to assigned treatment for Part 1 of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants 309 participants 155 participants 772 participants
46.9  (13.16) 46.4  (13.09) 47.9  (13.55) 46.9  (13.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 309 participants 155 participants 772 participants
Female
82
  26.6%
102
  33.0%
55
  35.5%
239
  31.0%
Male
226
  73.4%
207
  67.0%
100
  64.5%
533
  69.0%
Physician’s Global Assessment (PGA) score   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 309 participants 154 participants 771 participants
<3
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
3
202
  65.6%
206
  66.7%
111
  72.1%
519
  67.3%
4
95
  30.8%
95
  30.7%
41
  26.6%
231
  30.0%
5
11
   3.6%
7
   2.3%
2
   1.3%
20
   2.6%
[1]
Measure Description: The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration; 1= Minimal; 2 =Mild; 3= Moderate; 4= Marked; 5= Severe. Round average to the nearest whole number.
[2]
Measure Analysis Population Description: Analysis population includes participants with baseline PGA data.
Body weight  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 309 participants 155 participants 772 participants
<=90 kg
182
  59.1%
183
  59.2%
93
  60.0%
458
  59.3%
>90 kg
126
  40.9%
126
  40.8%
62
  40.0%
314
  40.7%
Prior exposure to biologics therapy for psoriasis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants 309 participants 155 participants 772 participants
Yes
71
  23.1%
71
  23.0%
35
  22.6%
177
  22.9%
No
237
  76.9%
238
  77.0%
120
  77.4%
595
  77.1%
[1]
Measure Description: The following therapies constitute biologics therapy for psoriasis: efalizumab, alefacept, infliximab, adalimumab, ustekinumab, and etanercept.
1.Primary Outcome
Title Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)
Hide Description The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Time Frame Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Number
Unit of Measure: Percentage of Participants
62.3 63.8 5.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 56.6
Confidence Interval (2-Sided) 95%
49.6 to 62.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 58.0
Confidence Interval (2-Sided) 95%
51.0 to 64.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)
Hide Description The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Time Frame Baseline and Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Number
Unit of Measure: Percentage of Participants
59.1 57.9 7.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 52.1
Confidence Interval (2-Sided) 95%
44.8 to 58.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 50.9
Confidence Interval (2-Sided) 95%
43.6 to 57.4
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Count of Participants
Unit of Measure: Participants
130
  42.2%
146
  47.2%
74
  48.1%
4.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.6%
0
   0.0%
1
   0.6%
5.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)
Hide Description A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.6%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (Extension Study)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 212 weeks (including 20-week follow-up)
Outcome Measure Data Not Reported
7.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to a Drug-Related AE (Extension Study)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 192 weeks
Outcome Measure Data Not Reported
8.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an Adverse Event (Extension Study)
Hide Description An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 192 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Participants With PASI-90 Response At Week 12
Hide Description The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Time Frame Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Number
Unit of Measure: Percentage of participants
35.4 34.6 2.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 32.9
Confidence Interval (2-Sided) 95%
26.8 to 38.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 32.1
Confidence Interval (2-Sided) 95%
25.9 to 38.0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With PASI-100 Response at Week 12
Hide Description The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Time Frame Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Measure Type: Number
Unit of Measure: Percentage of participants
14.0 13.9 1.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
8.3 to 17.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
8.0 to 17.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Baseline Dermatology Life Quality Index (DLQI) Score
Hide Description The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Mean (Standard Deviation)
Unit of Measure: Score on a scale
13.2  (6.87) 13.9  (6.68) 13.2  (7.25)
12.Secondary Outcome
Title Change From Baseline in the Participant DLQI Score at Week 12
Hide Description The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.
Time Frame Baseline and Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 308 309 154
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-10.0
(-10.7 to -9.4)
-9.8
(-10.4 to -9.1)
-2.3
(-3.1 to -1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-8.6 to -6.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
Method of Estimation Estimation Parameter Difference in least squares means
Estimated Value -7.4
Confidence Interval (2-Sided) 95%
-8.3 to -6.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With DLQI Score of 0 or 1 at Week 12
Hide Description The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Time Frame Week 12 (or end of trial if prior to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1)
Hide Arm/Group Description:
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Matching placebo administered SC once a week at Weeks 0 and 4.
Overall Number of Participants Analyzed 299 304 150
Measure Type: Number
Unit of Measure: Percentage of participants
44.2 41.5 5.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 200 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 38.9
Confidence Interval (2-Sided) 95%
31.9 to 45.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tildrakizumab 100 mg (Part 1), Placebo (Part 1)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 36.1
Confidence Interval (2-Sided) 95%
29.3 to 42.5
Estimation Comments [Not Specified]
Time Frame Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Adverse Event Reporting Description Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
 
Arm/Group Title Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Tildrakizumab 200 mg (Part 2) Tildrakizumab 100 mg (Part 2) Tildrakizumab 200 mg (Part 3) Tildrakizumab 100 mg (Part 3)
Hide Arm/Group Description Tildrakizumab 200 mg administered once a week at Weeks 0 and 4. Tildrakizumab 100 mg administered once a week at Weeks 0 and 4. Placebo administered once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg). Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12. Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3). Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
All-Cause Mortality
Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Tildrakizumab 200 mg (Part 2) Tildrakizumab 100 mg (Part 2) Tildrakizumab 200 mg (Part 3) Tildrakizumab 100 mg (Part 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Tildrakizumab 200 mg (Part 2) Tildrakizumab 100 mg (Part 2) Tildrakizumab 200 mg (Part 3) Tildrakizumab 100 mg (Part 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/308 (2.60%)      5/309 (1.62%)      1/154 (0.65%)      8/370 (2.16%)      7/374 (1.87%)      21/360 (5.83%)      14/316 (4.43%)    
Blood and lymphatic system disorders               
Anaemia  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Cardiac disorders               
Acute myocardial infarction  1  0/308 (0.00%)  0 1/309 (0.32%)  1 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Coronary artery disease  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Tachycardia  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Angina pectoris  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Eye disorders               
Cataract  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Macular fibrosis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Gastrointestinal disorders               
Pancreatitis acute  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Salivary gland enlargement  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Constipation  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 0/360 (0.00%)  0 0/316 (0.00%)  0
Diverticulum  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 0/360 (0.00%)  0 0/316 (0.00%)  0
Pancreatitis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 0/360 (0.00%)  0 0/316 (0.00%)  0
Food poisoning  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
General disorders               
Non-cardiac chest pain  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 2/360 (0.56%)  2 1/316 (0.32%)  1
Hepatobiliary disorders               
Cholecystitis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Cholelithiasis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Immune system disorders               
Anaphylactic reaction  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Infections and infestations               
Cellulitis  1  0/308 (0.00%)  0 1/309 (0.32%)  1 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 2/360 (0.56%)  2 0/316 (0.00%)  0
Epiglottitis  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Bone tuberculosis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Diverticulitis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 1/360 (0.28%)  1 0/316 (0.00%)  0
Gastroenteritis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 1/360 (0.28%)  1 0/316 (0.00%)  0
Gastroenteritis salmonella  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Sinusitis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Injury, poisoning and procedural complications               
Lower limb fracture  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Musculoskeletal and connective tissue disorders               
Rotator cuff syndrome  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 1/374 (0.27%)  1 0/360 (0.00%)  0 2/316 (0.63%)  3
Pancreatic carcinoma  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Squamous cell carcinoma of skin  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 1/374 (0.27%)  1 2/360 (0.56%)  2 2/316 (0.63%)  2
Benign biliary neoplasm  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Bowen's disease  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 1/316 (0.32%)  1
Carcinoma in situ of skin  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Nervous system disorders               
Presyncope  1  0/308 (0.00%)  0 0/309 (0.00%)  0 1/154 (0.65%)  1 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Lacunar infarction  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Cerebellar infarction  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Sciatica  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Transient ischaemic attack  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Psychiatric disorders               
Suicide attempt  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Renal and urinary disorders               
Nephrolithiasis  1  0/308 (0.00%)  0 1/309 (0.32%)  1 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Reproductive system and breast disorders               
Uterine haemorrhage  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Chronic obstructive pulmonary disease  1  1/308 (0.32%)  1 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Pneumothorax  1  0/308 (0.00%)  0 1/309 (0.32%)  1 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Pulmonary embolism  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Sleep apnoea syndrome  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 0/360 (0.00%)  0 1/316 (0.32%)  1
Skin and subcutaneous tissue disorders               
Psoriasis  1  0/308 (0.00%)  0 1/309 (0.32%)  1 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Vascular disorders               
Deep vein thrombosis  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 1/370 (0.27%)  1 0/374 (0.00%)  0 0/360 (0.00%)  0 0/316 (0.00%)  0
Aneurysm  1  0/308 (0.00%)  0 0/309 (0.00%)  0 0/154 (0.00%)  0 0/370 (0.00%)  0 0/374 (0.00%)  0 1/360 (0.28%)  1 0/316 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tildrakizumab 200 mg (Part 1) Tildrakizumab 100 mg (Part 1) Placebo (Part 1) Tildrakizumab 200 mg (Part 2) Tildrakizumab 100 mg (Part 2) Tildrakizumab 200 mg (Part 3) Tildrakizumab 100 mg (Part 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/308 (11.36%)      36/309 (11.65%)      23/154 (14.94%)      38/370 (10.27%)      42/374 (11.23%)      86/360 (23.89%)      78/316 (24.68%)    
Infections and infestations               
Nasopharyngitis  1  20/308 (6.49%)  20 24/309 (7.77%)  26 8/154 (5.19%)  8 17/370 (4.59%)  18 24/374 (6.42%)  24 44/360 (12.22%)  55 48/316 (15.19%)  66
Upper respiratory tract infection  1  15/308 (4.87%)  15 10/309 (3.24%)  10 9/154 (5.84%)  10 20/370 (5.41%)  21 16/374 (4.28%)  17 37/360 (10.28%)  43 26/316 (8.23%)  32
Skin and subcutaneous tissue disorders               
Psoriasis  1  0/308 (0.00%)  0 2/309 (0.65%)  2 8/154 (5.19%)  8 3/370 (0.81%)  4 2/374 (0.53%)  2 9/360 (2.50%)  9 9/316 (2.85%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT01722331     History of Changes
Other Study ID Numbers: 3222-010
2012-002255-42 ( EudraCT Number )
P07770 ( Other Identifier: Merck Protocol Number )
132284 ( Registry Identifier: JAPIC-CTI )
First Submitted: November 2, 2012
First Posted: November 6, 2012
Results First Submitted: March 28, 2018
Results First Posted: June 13, 2018
Last Update Posted: July 18, 2018